BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOGEN LIGHT SOURCE

    MDR report key: 25271688 · Received May 25, 2026

    Report

    Report Number
    3002808148-2026-17918
    Event Type
    Malfunction
    Date Received
    May 25, 2026
    Date of Event
    February 4, 2026
    Report Date
    May 25, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FCQ
    UDI-DI
    04953170024429
    PMA / PMN Number
    K981543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE MOST PROBABLE CAUSE OF THE MALFUNCTION IS TRACED TO COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER RETURNED THE HALOGEN LIGHT SOURCE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, BURNT-OUT BULB WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN ASSESSED THE CONDITION AND DETERMINED THAT THE DAMAGE WAS MOST LIKELY DUE TO HIGH-ENERGY INSTRUMENTS (SUCH AS HIGH-FREQUENCY DEVICES) WERE USED WITHOUT MAINTAINING SUFFICIENT DISTANCE FROM THE TIP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77035 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE FCQ SHIRAKAWA OLYMPUS CO., LTD. CLH-250 04953170024429

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown